Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 3

Conditions: Drug-refractory Paroxysmal Atrial Fibrillation

Treatments: Procedure: Pulmonary vein encircling plus roof ablation; Procedure: Pulmonary vein encircling

Study type: Interventional

Funder types: Other

Identifiers

NCT01203241

LARA-PAF

Details and patient eligibility

About

The aim of the present study is to assess whether left atrial roof ablation adds any benefit in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Drug-refractory paroxysmal atrial fibrillation

Exclusion criteria

• Hypo or hyperthyroidism
• Implantable defibrillation or pacemaker implanted
• Moderate or severe mitral valve disease or mitral prosthetic valve
• Ejection fraction less than 30%
• Left atrial anteroposterior diameter more than 50 mm.
• Previous atrial fibrillation ablation
• Left atrium thrombus
• Current infective disease or sepsis
• Pregnant women
• Current unstable angor
• Acute myocardial infarction in last 3 months
• Atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease
• Reduced expectancy of life (less than 12 months)
• Patient participating in another clinical study that investigates a drug or device
• Psychologically unstable patient or denies to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Conventional ablation

Active Comparator group

Description:

Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum

Treatment:

Procedure: Pulmonary vein encircling

Conventional ablation plus left atrial roof ablation

Active Comparator group

Description:

Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum plus creation of a radiofrequency line joining contralateral superior pulmonary veins throughout the left atrial roof.

Treatment:

Procedure: Pulmonary vein encircling plus roof ablation